País: Israel
Idioma: inglés
Fuente: Ministry of Health
ANAKINRA
MEGAPHARM LTD
L04AC03
SOLUTION FOR INJECTION
ANAKINRA 150 MG/ML
S.C
Required
SOBI SWEDISH ORPHAN BIOVITRUM AB
ANAKINRA
ANAKINRA
Kineret 100 mg solution for injection is indicated in adults for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, in patients with an inadequate response to methotrexate alone.Kineret 100 mg solution for injection is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), including:- Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA)- Muckle-Wells Syndrome (MWS)- Familial Cold Autoinflammatory Syndrome (FCAS) Kineret 100 mg solution for injection is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret 100 mg solution for injection should be given in combination with colchicine, if appropriate.
2016-03-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( - 1986 This medicine is dispensed with a physician’s prescription only KINERET 100 MG SOLUTION FOR INJECTION Pre-filled syringes Solution for Subcutaneous Injection Each pre-filled syringe contains: Anakinra 100 mg per 0.67 ml (150 mg/ml) For a list of inactive and allergenic ingredients in the medicine, see section 6 ”Additional Information“. Read this leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, consult your physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar. 1. What is this medicine intended for? Kineret 100 mg solution for injection is indicated for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, in adult patients with an inadequate response to methotrexate alone. Kineret 100 mg solution for injection is indicated for adults and children aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin-Associated Periodic Syndromes )CAPS(, a group of rare autoinflammatory diseases, including: - Chronic Infantile Neurological, Cutaneous, Articular Syndrome )CINCA(, also called Neonatal-Onset Multisystem Inflammatory Disease (NOMID). - Muckle-Wells Syndrome )MWS(. - Familial Cold Autoinflammatory Syndrome )FCAS(. Kineret 100 mg solution for injection is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret should be given in combination with colchicine, if appropriate. Kineret 100 mg solution for injection is a cytokine that belongs to the immunosuppressant group of medicines and is used for the treatment of Rheumatoid Arthritis and for the treatment of Cryopyrin- Associated Periodic Syndromes )CAPS(. This is a group of rare, autoinflammatory diseases including: Familial Cold Autoinf Leer el documento completo
1. NAME OF THE MEDICINAL PRODUCT Kineret 100 mg solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each graduated pre-filled syringe contains 100 mg of anakinra* per 0.67 ml (150 mg/ml). * Human interleukin-1 receptor antagonist (r-metHuIL-1ra) produced in _Escherichia coli _cells by recombinant DNA technology. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection (injection). Clear, colourless-to-white solution for injection that may contain some product-related translucent-to-white amorphous particles. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Kineret 100 mg solution for injection is indicated in adults for the treatment of the signs and symptoms of Rheumatoid Arthritis (RA) in combination with methotrexate, in patients with an inadequate response to methotrexate alone. Kineret 100 mg solution for injection is indicated in adults, adolescents, children and infants aged 8 months and older with a body weight of 10 kg or above for the treatment of Cryopyrin- Associated Periodic Syndromes (CAPS), including: - Neonatal-Onset Multisystem Inflammatory Disease (NOMID) / Chronic Infantile Neurological, Cutaneous, Articular Syndrome (CINCA) - Muckle-Wells Syndrome (MWS) - Familial Cold Autoinflammatory Syndrome (FCAS) Kineret 100 mg solution for injection is indicated for the treatment of Familial Mediterranean Fever (FMF). Kineret 100 mg solution for injection should be given in combination with colchicine, if appropriate. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Kineret 100 mg solution for injection treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of Rheumatoid Arthritis, FMF and CAPS, respectively. Posology RA: Adults The recommended dose of Kineret 100 mg solution for injection is 100 mg administered once a day by subcutaneous injection. The dose should be administered at approximately the same time each day. CAPS: Adults, adolescents, children and infants aged 8 months and older with Leer el documento completo